Recently in numerous public occasions, Vice Minister of Health and Welfare Shih Chung-liang has been mentioning the three bills aiming to promote the development of regenerative medicine that are slated to undergo pre-announcement towards the end of December and expected to be submitted for review by the legislature in 2022.

Regarding the three bills, Vice Minister Shih said the first of the three bills is called “Development of Regenerative Medicine Act”, which aims to enable government support in the development of related industries, focusing on talent cultivation, providing tax incentives, as well as establishing a national cell bank. “We hope to establish a foundation to oversee the establishment and management of a national cell bank to store cells that are more difficult to produce and have a higher risk of failure, as well as cells submitted by super donors,” Vice Minister Shih said.

The second bill, called "Regulations on the Implementation and Management of Regenerative Medicine," is to manage its use. Vice Minister Shih further explained, "In the future, individuals may want to store his or her cells at a young age for emergencies, so cell banks need to be managed. Furthermore, regenerative medicine cannot be practiced at just any hospitals, so its execution must also be managed. In addition, management of laboratory processes is also necessary, as well as the protection of patient rights, therefore, insurance must be included in the regulations of the bill.”

The third of the bills is the "Act Governing Regenerative Medicine Preparations," which Vice Minister Shih said aims to accelerate production volume and automation by establishing sound quality standards. Furthermore, while current regenerative medicine mainly uses autologous cells, it is expected that future treatments will trend towards allogeneic cells, to take advantage of allogenization and automation to enable prices to go down after economies of scale is achieved.

Most importantly, amid the pandemic, the Taiwan Food and Drug Administration unprecedentedly approved two headline-grabbing regenerative drugs, namely, Zolgensma for the treatment of the rare disease spinal muscular atrophy in December of 2020, and Kymriah for the treatment of leukemia in September of 2021.

Vice Minister Shih concluded that the two landmark drug approvals indicate that the government has made gained experience in reviewing regenerative medicine products, representing a significant step forward. Coupled with the planned review of the three bills by the Legislative Yuan, the field of regenerative medicine will be as dynamic and exciting as Vice Minister Shih envisions.

[2021-12-14/Wealth Magazine]